Phenylephrine Hydrochloride Eye Drops by Caplin Steriles Receive USFDA Nod

On May 24, 2024, Caplin Point Laboratories Limited informed the stock exchanges that the company’s subsidiary, Caplin Steriles Limited, has received final approval from the United States Food and Drug Administration (USFDA). The approval is for its Abbreviated New Drug Application (ANDA) for Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% (eye drops).

Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% (eye drops) is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) from Alcon Research LLC.

Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% is prescribed to dilate the pupil of the eyes.

According to IQVIATM (IMS Health), Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% had US sales of approximately $32 million for the 12-month period ending Mar 2024.

Earlier in April 2024, Caplin Steriles Limited got approval from the United States Food and Drug Administration for its Abbreviated New Drug Application Ofloxacin Ophthalmic Solution USP 0.3% (eye drops). It is a generic therapeutic equivalent version of OCUFLOX Ophthalmic Solution of Allergan Inc. According to IQVIATM (IMS Health), Ofloxacin Ophthalmic Solution USP 0.3% had US sales of approximately $52 million for the 12-month period ending December 2023.

About Caplin Steriles Limited 

Caplin Steriles Limited is a sterile product manufacturing company. The company holds approvals from various regulatory bodies, including the EU-GMP, US FDA, INVIMA and ANVISA. With 41 ANDAs filed in the USA independently and in collaboration, it has secured 28 approvals. The company is developing a portfolio of over 40 simple and complex Injectable and Ophthalmic products for filing within the next 4 years. Additionally, it has multiple products filed and approved in non-US markets like Australia, Mexico, South Africa and Canada.

About Caplin Point Laboratories Limited 

Caplin Point Laboratories Limited is a fast-growing pharmaceutical company with a distinctive business model that caters primarily to emerging markets in Latin America and Africa.

On May 24, 2024, the share price of Caplin Point Laboratories Ltd opened at ₹1,314.95, touching the day’s high at ₹1,339.00, as of 1:02 PM on the NSE.

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